SUPPLY CHAIN ARTICLES
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Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned
One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain.
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Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward
Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. But given how “collaborative” many of these sources of inspiration are, I’ve introduced each of my takeaways with a surprisingly relevant (albeit bad) art-themed pick-up line. After all, if there’s one sector that knows it takes more than one to “tango,” it’s the mRNA industry.
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Addressing Challenges In Serialization For Complex Therapeutics
The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
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“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles
In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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The single guide RNA (sgRNA) is one of the key components of successful CRISPR gene editing. Here we cover all the important aspects of sgRNA and Synthego’s sgRNA products.
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Drive the efficiency and resiliency of supply chains by integrating automation, AI, and effective communication, ensuring the successful distribution of lifesaving medicinal products.
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Explore a program focused on achieving process consistency through risk mitigation in four key areas: raw materials sourcing, equipment, manufacturing processes, and finished product testing.
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Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
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As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.
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Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.